US6217554B1 - Methods and apparatus for delivering substances into extravascular tissue - Google Patents
Methods and apparatus for delivering substances into extravascular tissue Download PDFInfo
- Publication number
- US6217554B1 US6217554B1 US09/249,751 US24975199A US6217554B1 US 6217554 B1 US6217554 B1 US 6217554B1 US 24975199 A US24975199 A US 24975199A US 6217554 B1 US6217554 B1 US 6217554B1
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- US
- United States
- Prior art keywords
- hollow needles
- catheter
- tubular member
- sheath
- extravascular tissue
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M25/0084—Catheter tip comprising a tool being one or more injection needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
- A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22072—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
- A61B2017/22074—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
- A61B2017/22077—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel with a part piercing the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00392—Transmyocardial revascularisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M25/0084—Catheter tip comprising a tool being one or more injection needles
- A61M2025/0085—Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
- A61M2025/0086—Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
- A61M2025/0096—Catheter tip comprising a tool being laterally outward extensions or tools, e.g. hooks or fibres
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
Definitions
- the present invention relates to apparatus and methods for delivering a therapeutic or diagnostic agent into extravascular tissue. More particularly, the present invention provides a catheter for delivering therapeutic or diagnostic materials to cardiac tissue using the cardiac vasculature.
- TMR transmyocardial revascularization
- VEG-F vascular endothelial growth factor
- diagnostic agents such as radio-isotopes or contrast agents
- Apparatus and methods are known for injecting pharmacological agents into the walls of vessels, and surrounding tissue, to reduce restenosis following the use of minimally-invasive techniques, such as angioplasty.
- minimally-invasive techniques such as angioplasty.
- angioplasty balloons often injure a large percentage of the endothelium that they contact, and the healing response may itself lead to recurrence of the stenosis.
- Methods and apparatus therefore have been developed for injecting drugs, such as anti-platelet, anti-coagulant, anti-proliferative and/or anti-inflammatory drugs, into the wall of a treated vessel, or adjacent tissue, to discourage restenosis.
- U.S. Pat. No. 5,464,395 to Faxon et al. describes a system for delivering therapeutic or diagnostic agents to tissue surrounding a vessel.
- a needle cannula having a tissue-piercing tip is extended from a delivery catheter to penetrate a selected distance into tissue surrounding the vessel to inject a therapeutic or diagnostic agent.
- the device includes a balloon for dilating the vessel prior to extending the needle cannula. If multiple needle cannulas are used, each needle cannula requires a separate lumen and must be individually positioned within the tissue to be treated.
- U.S. Pat. No. 5,693,029 to Leonhardt describes a catheter having a plurality of fixed-length needle assemblies that are selectively extended to pierce the walls of a lumen and inject a therapeutic agent.
- the therapeutic agent is delivered to the needle assemblies via a common channel.
- the catheter includes a balloon that is inflated to deploy the needle assemblies, and a retraction mechanism that retracts the needle assemblies once the balloon is deflated.
- each needle cannula in the Faxon device must be separately deployed and positioned; consequently, the use of multiple needle cannulas may be both time consuming and laborious.
- the Leonhardt device employs relatively short fixed-length needle assemblies, that device cannot be used for administering a therapeutic or diagnostic agent at various depths within the myocardium.
- the retraction mechanism used in the Leonhardt device inherently poses risks to the patient's health should that mechanism fail.
- a therapeutic agent such as drug or angiogenic growth factor
- a diagnostic agent such as a radio-isotope or contrast agent
- It is a still further object of this invention provide methods and apparatus for administering a therapeutic or diagnostic agent at multiple sites in extravascular tissue at various depths.
- a catheter for percutaneously delivering a therapeutic or diagnostic agent to the heart comprising a sheath, a tubular member slidably disposed within the sheath, and a plurality of hollow needles coupled to the tubular member.
- the plurality of hollow needles have a delivery position, wherein the plurality of hollow needles are retracted within the sheath, and an extended position, wherein the plurality of hollow needles extend beyond a distal endface of the sheath and curve outwardly to penetrate extravascular tissue.
- the catheter is adapted to be disposed in the coronary venous vasculature to inject a therapeutic or diagnostic agent at selected depths into the myocardium.
- the catheter preferably includes a balloon disposed on the outer sheath that may be used to apply pressure to seal the injection sites after a therapeutic or diagnostic agent is injected. Methods of using the catheter of the present invention also are provided.
- FIG. 1 is a side view of an illustrative embodiment of a catheter system constructed in accordance with the present invention
- FIGS. 2A and 2B are, respectively, a cross-sectional view of the distal end of the catheter of FIG. 1, and an end view taken along view line 2 B— 2 B of FIG. 2A, in the delivery position;
- FIGS. 3A and 3B are, respectively, a cross-sectional view of the distal end of the catheter of FIG. 1, and an end view taken along view line 3 B— 3 B of FIG. 3A, in the extended position;
- FIGS. 4A, 4 B and 4 C illustrate methods of using the catheter of FIG. 1 to inject a therapeutic or diagnostic agent into extravascular tissue.
- the present invention relates generally to apparatus and methods for administering a therapeutic or diagnostic agent to extravascular tissue, especially the heart.
- the invention is described hereinafter as particularly useful for administering a therapeutic and diagnostic agent to the heart, the methods and apparatus of the present invention advantageously may be used for administering therapeutic or diagnostic agents to other organs and vessels.
- Catheter 10 includes outer sheath 11 having proximal end 12 coupled to handle 13 and distal end 14 having inflatable balloon 15 .
- Handle 13 includes distal portion 16 joined to outer sheath 11 , and proximal portion 17 , which is engaged by threads 18 with distal portion 16 .
- Syringe 19 containing a therapeutic or diagnostic drug to be injected into a patient's tissue, is coupled to proximal portion 17 at hub 20 .
- Guidewire 21 extends through hub 20 and out of the distal end of catheter 10 .
- Catheter 10 preferably is 30 cm or longer, and is adapted to be percutaneously and transluminally inserted into a vessel of the patient's vasculature, such as the coronary venous vasculature.
- tubular member 25 is arranged for sliding movement in outer sheath 11 , and has a proximal end coupled to handle member 17 and distal end 26 having endcap 27 .
- Endcap 27 has a plurality of hollow needles 28 affixed to distal endface 29 .
- Inner member 30 is disposed coaxially within tubular member 25 to form annular lumen 31 .
- Inner member 30 includes lumen 32 , through which guide wire 21 is slidably disposed.
- Tubular member 25 and inner member 30 are coupled to proximal portion 17 of handle 13 so that when proximal portion 17 is rotated within distal portion 16 of handle 13 , tubular member 25 and inner member 30 are extended or retracted a predetermined distance.
- Inflation lumen 33 couples balloon 15 to a source of inflation medium, such as a syringe (not shown), via handle 13 .
- Outer sheath 11 , tubular member 25 and inner member 30 preferably comprise a material commonly used in catheter construction, such as polyethylene, polyvinyl chloride or polyurethane.
- tubular member 25 may include ring 34 , formed of a layer of radio-opaque marker material, such as gold, disposed near endcap 29 .
- Radio-opaque ring 34 may be employed to assist in orienting catheter 10 so that the distal end of tubular member 25 is aligned with a desired treatment site in the patient's vasculature.
- Annular lumen 31 extends from the proximal end of catheter 10 , where it is coupled to syringe 19 , to endcap 29 at distal end 14 .
- Hollow needles 28 protrude longitudinally from distal endface 29 , and are in fluid communication with annular lumen 31 .
- Hollow needles 28 preferably comprise a resilient material, such as nickel titanium or stainless steel, and are biased to curve outwardly away from the longitudinal of catheter 10 when extended beyond distal endface 36 of outer sheath 11 .
- Hollow needles 28 each have non-coring tip 35 and opening 37 and a lumen that communicates with annular lumen 31 .
- Hollow needles 28 are designed to readily pierce tissue, to enable injection of a therapeutic or diagnostic agent into extravascular tissue.
- hollow needles 28 are disposed in a semi-circular pattern, as illustrated in FIG. 2 B. This arrangement ensures that when the catheter is inserted and properly oriented, for example, in the coronary sinus or great cardiac vein, the needles will extend only into the myocardium, and not puncture the circumference of the vessel adjacent the pericardial sac.
- hollow needles 28 may be arranged in a different pattern, for example to cover more or less of the circumference of endcap 29 , depending upon the intended application of catheter 10 .
- tubular member 25 when tubular member 25 is retracted proximally, for example, by rotating proximal portion 17 of handle 13 relative to distal portion 16 , hollow needles 28 are retracted into outer sheath 11 .
- hollow needles 28 When retracted in outer sheath 11 , hollow needles 28 are closely bunched together, and assume a delivery position substantially parallel to a longitudinal axis of outer sheath 11 . In the delivery position, outer sheath 11 prevents tips 32 from puncturing the patient's vasculature during insertion and withdrawal of catheter 10 .
- catheter 10 is shown with hollow needles 28 in the extended position.
- the extended position may be attained, for example, by rotating proximal portion 17 of handle 13 relative to distal portion 16 , so that tubular member 25 is translated in the distal direction.
- hollow needles 28 extend beyond distal endface 36 of outer sheath 11 , hollow needles curve outwardly away from the longitudinal axis of the catheter, due to the bias of the needles.
- hollow needles 28 curve radially away from endcap 29 to pierce the vessel wall and surrounding tissue.
- catheter 10 enables a clinician to adjust the depth to which tips 32 of hollow needles 28 are deployed by controlling relative motion between tubular member 25 and outer sheath 11 using handle 13 .
- handle 13 may include gradations that provide correspondence between relative motion of handle portions 16 and 17 and extension of hollow needles 28 .
- catheter 10 permits a therapeutic or diagnostic agent to be injected in a relatively widespread pattern without repeatedly repositioning the catheter.
- Catheter 10 is first inserted percutaneously and transluminally into a patient's vessel V under fluoroscopic guidance. For example, if it is desired to inject an angiogenic growth factor or other bioactive agent, e.g., FGF-I or VEG-F, into the myocardium, catheter 10 may be advanced along guide wire 21 via a femoral vein, the inferior vena cava and the right atrium into the coronary sinus.
- an angiogenic growth factor or other bioactive agent e.g., FGF-I or VEG-F
- Radio-opaque ring 34 may be used to orient distal end 14 of catheter 10 adjacent a desired treatment site. Specifically, catheter 10 may be rotated so that when hollow needles 28 are extended from outer sheath 11 , all of the needles pierce the epicardium, and few or none pierce the opposing vessel wall (i.e., adjacent the pericardial sac).
- handle 13 is operated to translate tubular member 25 in the distal direction to extend hollow needles 28 .
- hollow needles 28 extend beyond distal endface 36 of outer sheath 11 , the hollow needles begin to curve outwardly, so that tips 32 pierce the epicardium and myocardium adjacent to vessel V a first predetermined depth.
- Syringe 19 then is operated to inject therapeutic or diagnostic agent A into the tissue to form pockets P.
- Handle member 13 may then be operated a second time to further extend tubular member 25 , thereby causing hollow needles 28 to further penetrate into the tissue, as shown in FIG. 4 B.
- Syringe 19 may then be actuated a second time to inject therapeutic or diagnostic agent A into the tissue to form additional pockets P′.
- handle 13 may be actuated to control the depth of penetration of hollow needles 28 to inject a therapeutic or diagnostic agent at a series of locations along a single needle track.
- handle 13 is operated to withdraw tubular member 25 proximally into outer sheath 11 , thereby causing hollow needles 28 to be retracted from the tissue and back into outer sheath 11 .
- catheter 10 may be removed from the patient or repositioned at another treatment site.
- catheter 10 may be advanced over guide wire 21 so that balloon 15 is positioned adjacent puncture wounds W formed by deployment of hollow needles 28 .
- Balloon 15 then may be inflated via inflation lumen 33 to apply a low pressure to puncture wounds W for a short interval of time, e.g., a few minutes, to seal the wounds and prevent therapeutic or diagnostic agent A from migrating along the needle track into vessel V.
- Balloon 15 then is deflated and catheter 10 may be removed from the patient or re-positioned at another treatment site for further injections.
Abstract
Description
Claims (20)
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US09/249,751 US6217554B1 (en) | 1999-02-12 | 1999-02-12 | Methods and apparatus for delivering substances into extravascular tissue |
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US09/249,751 US6217554B1 (en) | 1999-02-12 | 1999-02-12 | Methods and apparatus for delivering substances into extravascular tissue |
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Cited By (155)
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